Expert system and method

ABSTRACT

A medical device programmer and a method of operation in which a first data value is received and used in the execution of one or more algorithms. One or more suggested pulse generator settings are calculated from the one or more algorithms based on the first data value, and the one or more suggested pulse generator settings are displayed on an interactive display screen of the medical device programmer. In one embodiment, the first data value is a duration interval of a QRS complex. From the duration interval, suggestions are made as to one or more ventricular chambers in which to provide pacing pulses. Additionally, pacing intervals for an AV delay are suggested based on measured P-R intervals, or pacing intervals for an LV offset are suggested based on a measured duration interval of a V-V-interval between a right ventricular event and a left ventricular event.

CROSS REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.11/624,035, filed on Jan. 17, 2007, which is a continuation of U.S.patent application Ser. No. 09/748,791, filed on Dec. 26, 2000, nowissued as U.S. Pat. No. 7,181,285, the specifications of which areincorporated herein by reference.

TECHNICAL FIELD

The present invention relates to medical devices and in particular to amedical device programmer having an expert system to suggest therapysettings based on a patient profile.

BACKGROUND

When functioning properly, the human heart maintains its own intrinsicrhythm, and is capable of pumping adequate blood throughout the body'scirculatory system. However, some people have irregular cardiac rhythms,referred to as cardiac arrhythmias. Such arrhythmias result indiminished blood circulation. One mode of treating cardiac arrhythmiasuses drug therapy. Drugs are often effective at restoring normal heartrhythms. However, drug therapy is not always effective for treatingarrhythmias of certain patients. For such patients, an alternative modeof treatment is needed. One such alternative mode of treatment includesthe use of a cardiac rhythm management system. Such systems are oftenimplanted in the patient and deliver therapy to the heart.

Cardiac rhythm management systems include, among other things,pacemakers, also referred to as pacers. Pacers deliver timed sequencesof low energy electrical stimuli, called pace pulses, to the heart, suchas via an intravascular leadwire or catheter (referred to as a “lead”)having one or more electrodes disposed in or about the heart. Heartcontractions are initiated in response to such pace pulses (this isreferred to as “capturing” the heart). By properly timing the deliveryof pace pulses, the heart can be induced to contract in proper rhythm,greatly improving its efficiency as a pump. Pacers are often used totreat patients with bradyarrhythmias, that is, hearts that beat tooslowly, or irregularly.

Cardiac rhythm management systems also include cardioverters ordefibrillators that are capable of delivering higher energy electricalstimuli to the heart. Defibrillators are often used to treat patientswith tachyarrhythmias, that is, hearts that beat too quickly. Suchtoo-fast heart rhythms also cause diminished blood circulation becausethe heart isn't allowed sufficient time to fill with blood beforecontracting to expel the blood. Such pumping by the heart isinefficient. A defibrillator is capable of delivering a high energyelectrical stimulus that is sometimes referred to as a defibrillationcountershock. The countershock interrupts the tachyarrhythmia, allowingthe heart to reestablish a normal rhythm for the efficient pumping ofblood. In addition to pacers, cardiac rhythm management systems alsoinclude, among other things, pacer/defibrillators that combine thefunctions of pacers and defibrillators, drug delivery devices, and anyother implantable or external systems or devices for diagnosing ortreating cardiac arrhythmias.

One problem faced by cardiac rhythm management systems is the treatmentof heart failure (also referred to as “HF”). Heart failure, which canresult from long-term hypertension, is a condition in which the musclein the walls of at least one of the right and left sides of the heartdeteriorates. By way of example, suppose the muscle in the walls of theleft side of the heart deteriorates. As a result, the left atrium andleft ventricle become enlarged, and the heart muscle displays lesscontractility. This decreases cardiac output of blood through thecirculatory system which, in turn, may result in an increased heart rateand less resting time between heartbeats. The heart consumes more energyand oxygen, and its condition typically worsens over a period of time.

In the above example, as the left side of the heart becomes enlarged,the intrinsic heart signals that control heart rhythm can also beimpaired. Normally, such intrinsic signals originate in the sinoatrial(SA) node in the upper right atrium, traveling through and depolarizingthe atrial heart tissue such that resulting contractions of the rightand left atria are triggered. The intrinsic atrial heart signals arereceived by the atrioventricular (AV) node which, in turn, triggers asubsequent ventricular intrinsic heart signal that travels through anddepolarizes the ventricular heart tissue such that resultingcontractions of the right and left ventricles are triggeredsubstantially simultaneously.

In the above example, where the left side of the heart has becomeenlarged due to heart failure, however, the ventricular intrinsic heartsignals may travel through and depolarize the left side of the heartmore slowly than in the right side of the heart. As a result, the leftand right ventricles do not contract simultaneously, but rather, theleft ventricle contracts after the right ventricle. This reduces thepumping efficiency of the heart. Moreover, in the case of left bundlebranch block (LBBB), for example, different regions within the leftventricle may not contract together in a coordinated fashion.

Heart failure can be treated by biventricular coordination therapy thatprovides pacing pulses to both right and left ventricles. See, e.g.,Mower U.S. Pat. No. 4,928,688. Heart failure may also result in anoverly long atrioventricular (AV) delay between atrial and ventricularcontractions, again reducing the pumping efficiency of the heart.Providing heart failure patients with improved pacing and coordinationtherapies for improving AV-delay, coordinating ventricular contractions,or otherwise increasing heart pumping efficiency continues to be area inwhich improved techniques and therapy protocols are needed.

SUMMARY

The present subject matter provides suggestions for, and execution of,pacing and coordination therapies for improving AV-delay, coordinatingventricular contractions, and/or otherwise increasing heart pumpingefficiency of a patient's heart. In one embodiment, a medical deviceprogrammer is used to receive and/or determine a first data value ofpatient specific information that is used in the execution of one ormore algorithms. One or more suggested pulse generator settings arecalculated from the one or more algorithms based on the first datavalue, and the one or more suggested pulse generator settings aredisplayed on an interactive display screen of the medical deviceprogrammer. All or some of the one or more suggested pulse generatorsettings are then either programmed into the pulse generatorautomatically or under the direction of the physician.

The first data value derived from the patient includes any number ofmeasurements made from one or more cardiac signals. In one embodiment,the first data value is a duration interval of one or more of a QRScomplex. From the duration interval, determinations and/or suggestionsare made as to one or more ventricular chambers in which to providepacing pulses. For example, a duration interval of the QRS complex ismeasured from a cardiac signal and used as the first data value with theone or more algorithms. In one embodiment, the duration interval isprovided by the physician as the first data value to be used with theone or more algorithms. From the one or more algorithms, a determinationis made as which ventricular chamber, or both ventricular chambers toprovide pacing pulses based on the duration interval of the QRS complex.In one embodiment, the determination is presented as a suggestion on amedical device programmer as to which, or both, ventricular chambers toprovide pacing pulses to.

In an additional embodiment, first data value is a duration interval ofa P-R interval between one or more of an atrial event and a ventricularevent. From the P-R interval, a determination is made on an indicatedpacing interval, T_(n), for the AV delay based on the P-R-interval. Inone embodiment, this determination of the AV delay is presented as asuggested setting on a medical device programmer for programming animplantable pulse generator. In a further embodiment, the first datavalue is a duration interval of a V-V-interval between a rightventricular event and a left ventricular event. From the V-V-interval, adetermination is made for the pacing interval, T_(n), for an LV offsetvalue. In one embodiment, this determination of the LV offset ispresented as a suggested setting one a medical device programmer.

Any combination of the derived pulse generator settings are thenprogrammed into the pulse generator under the direction of thephysician. In one embodiment, this is done by the physician after areview of the settings on the medical device programmer. In addition,the medical device programmer can automatically program one or more ofthe derived pulse generator settings with this information being madeavailable to the physician. Any or all of the derived pulse generatorsettings can be changed, deleted, or used in subsequent determinationsof the pulse generator settings under the direction of the physician orautomatically by the algorithms of the present subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is one embodiment of a method according to the present subjectmatter;

FIG. 2 is one embodiment of a method according to the present subjectmatter;

FIG. 3 is one embodiment of a method according to the present subjectmatter;

FIG. 4 is one embodiment of a method according to the present subjectmatter;

FIG. 5 is one embodiment of a method according to the present subjectmatter;

FIG. 6 is one embodiment of a method according to the present subjectmatter;

FIG. 7 is a perspective of a medical device programmer and animplantable medical device with leads according to one embodiment of thepresent subject matter;

FIG. 8 is a block diagram of a medical device programmer according toone embodiment of the present subject matter;

FIG. 9A is a schematic view of an interactive display screen of amedical device programmer according to one embodiment of the presentsubject matter;

FIG. 9B is a schematic view of an interactive display screen of amedical device programmer according to one embodiment of the presentsubject matter;

FIG. 9C is a schematic view of an interactive display screen of amedical device programmer according to one embodiment of the presentsubject matter;

FIG. 10 is a schematic view of an implantable medical device and aheart, in which portions of the heart have been removed to show detail,according to one embodiment of the present subject matter.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings that form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that the embodiments may be combined, or that otherembodiments may be utilized and that structural, logical and electricalchanges may be made without departing from the spirit and scope of thepresent invention. The following detailed description is, therefore, notto be taken in a limiting sense, and the scope of the present inventionis defined by the appended claims and their equivalents.

In the following, the term “AV-Delay” is used to refer to a therapysetting “AV-Delay”. In contrast, the time interval between an atrialevent and a ventricular event will be referred to as a “P-R interval”.

The present methods and apparatus will be described in applicationsinvolving a medical device programmer and implantable medical devicesfor treating heart failure including, but not limited to, implantablepulse generators such as pacemakers, cardioverter/defibrillators,pacer/defibrillators, and biventricular or other multi-site coordinationdevices. However, it is understood that the present methods andapparatus may be employed in unimplanted devices, including, but notlimited to, external pacemakers, cardioverter/defibrillators,pacer/defibrillators, biventricular or other multi-site coordinationdevices, monitors and recorders.

Medical device programmers are the primary clinical tools used forchanging settings, retrieving diagnostic data and conducting noninvasivetests on a patient's implantable pulse generator. These devices useinductive coils to provide bidirectional telemetry between theprogrammer and the implantable pulse generator. With the programmer,physicians receive and view stored cardiac and system data from theimplantable pulse generator and send programming instructions back downto the implantable pulse generator.

While medical device programmers are able to display a variety ofinformation received from the implantable pulse generator, the physicianmust still review and interpret the information. From this informationthe physician makes their decision on how best to set programmablevariables of the implantable pulse generator.

Manufacturers and physicians are sensitive to the role thattime-efficient programming of implantable pulse generators plays in theproductivity of a pacing clinic. Given these time pressures, havingprogramming suggestions presented to the physician would be a convenientand time saving measure. In addition, by having a list of programmingsuggestions the physician is better able to understand the range ofoptions and possible therapy protocols available to best meet thepatient's needs.

The present subject matter provides suggestions for therapy settings indevices for treating heart failure. Such devices can include, but arenot limited to, implantable pulse generators such as pacemakers andimplantable cardioverter defibrillators (ICDs). The suggested therapysettings are developed from information derived from one or more cardiacsignals sensed from the patient. In one embodiment, these cardiacsignals are sensed with the patient's implantable medical device.Alternatively, other means for sensing and/or recording a patient'scardiac signals are useful. Because the patient's own cardiac signal(s)are used, the suggestions for and/or programmed therapy settings aretailored to the patient.

In one embodiment, the present subject matter is implemented in amedical device programmer that receives or determines a patient'scardiac information (e.g., cardiac signal(s) sensed with theirimplantable pulse generator). In one embodiment, the cardiac informationincludes, but is not limited to, time intervals of cardiac complexesdetected in the cardiac signals, along with the location of leads andelectrodes within the patient's heart. This information is used todevelop a patient profile. In one embodiment, the patient profile isthen used to develop settings for programmable parameters within theimplantable pulse generator. In one embodiment, the programmer displaysthe settings for consideration by the physician. Alternatively, theprogrammer communicates one or more of the calculated settings to theimplantable pulse generator. The settings communicated to the pulsegenerator are then displayed on the programmer. The settings can eitherbe accepted or be changed and programmed into the pulse generator.Alternatively, the suggested settings can be used in subsequent patientprofile calculations.

FIG. 1 shows one embodiment of a method 100 according to the presentsubject matter. At 110, a first data value is received. In oneembodiment, the first data value is patient specific information derivedfrom one or more cardiac signals sensed from the patient. Patientspecific information can include, but is not limited to, a durationinterval of one or more of a QRS complex, and/or a duration interval ofone or more P-R intervals, a duration interval of a V-V-interval, whereany of duration intervals can be determined from one representativeinterval, or an average or mean value of intervals. In addition, thefirst data value is determined automatically from sensed or recordedcardiac signals. Alternatively, the first data value is determined frommanual measurements made on scaled images of the cardiac signals.

At 120, one or more algorithms are executed, where the one or morealgorithms use the first data value. In one embodiment, the one or morealgorithms are executed within a medical device programmer. The one ormore algorithms, however, could be executed in a device having theability to receive the first data value and the ability to execute theone or more algorithms. At 130, one or more suggested pulse generatorsettings are calculated with the one or more algorithms based on thefirst data value. The present subject matter is, however, not limited tousing only the first data value in determining the suggested pulsegenerator settings. Additional data and/or patient information mightalso be used in, or in conjunction with, the one or more algorithms indetermining the pulse generator settings. The one or more suggestedpulse generator settings are displayed at 140. In one embodiment, thesuggested pulse generator settings are displayed on an interactivedisplay screen. In one embodiment, the interactive display screen ispart of the medical device programmer.

In addition to using the first data value to determine the one or moresuggested pulse generator settings, the present subject matter allowsfor two or more determinations of the one or more suggested pulsegenerator settings to be made. From the two or more determinations, asingle set of the one or more suggested pulse generator settings can bederived. For example, an average of the one or more suggested pulsegenerator settings can be determined for N samples. The averagedsuggested settings are then displayed.

FIG. 2 shows an additional embodiment of a method 200 according to thepresent subject matter. The method 200 generally proceeds through threestages, where each of the stages is performed sequentially, and eachstage is completed prior to a subsequent stage being started. It isrecognized, however, that the present subject matter need not proceedthrough set stages, where the procedure used in present subject mattercan be performed at least partially or completely simultaneously afterreceiving all necessary information to perform the algorithms.

At 210, a cardiac signal is sensed from a patient's heart. In oneembodiment, the cardiac signal is electronically sensed, where thesignal is a far-field signal sensed in a variety of ways. For example,the cardiac signal is sensed through the use of a surface 12-lead ECGmeasurement. Alternatively, the cardiac signal is sensed through the useof a programmer recorded monitor (PRM) surface ECG system.

At 220, a patient profile is acquired from the cardiac signal. In oneembodiment, the patient profile includes a first data value derived fromthe sensed cardiac signal. For example, the first data value is aduration interval of one or more QRS complexes detected in the patient'ssensed cardiac signal. Alternatively, the first data value is a P-Rinterval value or a V-V-interval value between a left and rightventricular contraction. Alternatively, a previous patient profile couldbe updated by the medical device programmer with the first data value,where data values from one or more patient profiles are used indetermining a final data value to be used in the algorithms.

The medical device programmer then receives the first data value at 230.In one embodiment, the first data value is provided to the medicaldevice programmer. Alternatively, the medical device programmerdetermines the first data value. Once the medical device programmerreceives the first data value at 130, the electronic control circuitrywithin the programmer executes one or more algorithms at 140, where theone or more algorithms use the first data value. In one embodiment, theelectronic control circuitry within the programmer is controlled by theuser to execute the one or more algorithms. Alternatively, theelectronic control circuitry executes the one or more algorithmsautomatically once the first data value is received.

At 250, the electronic control circuitry calculates suggested pulsegenerator settings from the one or more algorithms using the first datavalue. Suggested pulse generator settings are displayed on a displayscreen at 260. In one embodiment, the suggested pulse generator settingsare, in addition to being displayed on the display screen, alsoprogrammed into the pulse generator. The user then reviews theprogrammed information. Based on the review, the user can then acceptthe programmed values. Alternatively, the user can change one or more ofthe values. In addition, the user could also request the values berecalculated using a newly derived first data value, or recalculatedusing a first data value derived from the first data value used indetermining the pulse generator settings and a newly derived first datavalue, or a default first data value for the patient. The user views thesuggested pulse generator settings and decides to accept some or all thesuggested values, change some or all the suggested values and toprogram, not program or change the programmed the suggested values intothe implantable medical device.

In one example, the implantable pulse generator includes pacemakerfunctions, where the pacemaker functions could be operating in anynumber of implantable or external rhythm management devices (e.g., ICDsand/or pacemakers, implantable or external). Suggested pulse generatorsettings for the pacemaker function include, but are not limited to,which of either or both ventricular chambers to pace, a time intervalfor an AV-delay (the length of time between an atrial sensed or atrialpaced event and the delivery of a ventricular output pulse, unlessshortened by a sensed intrinsic ventricular event prior to the AVinterval timing out) and/or a time interval for an LV offset (the lengthof time between a sensed or paced event in a first ventricle and thedelivery of an output pulse to a second ventricle). Deriving thesesuggested pulse generator settings will be more fully elaborated onbelow.

FIG. 3 shows an additional embodiment of a method 300 according to thepresent subject matter. At 310, a cardiac signal that includes QRScomplexes is sensed from a patient's heart through the use of a surface12-lead ECG measurement or a PRM surface ECG system. At 320, a patientprofile is acquired from the sensed cardiac signal. In one embodiment,the patient profile includes the first data value as previouslydescribed. In the present embodiment, the first data value is a durationinterval of one or more QRS complexes detected in the patient's sensedcardiac signal. Measuring the duration interval of QRS complexes isaccomplished in any number of ways. For example, the duration intervalof the QRS complex is measured manually. In one embodiment, manuallymeasuring the QRS complex duration interval is accomplished by sensingthe cardiac signal using either of the above-mentioned techniques andrecording/printing the sensed cardiac signal on a paper strip chartrecording at 50 millimeters/second. In one embodiment, the QRS complexduration intervals are measured from cardiac signals sensed on leads II,V₁ and V₆ of a 12-lead ECG, where lead V₆ is placed at the midaxillaryline, at the same level as lead V₄. In one embodiment, the QRS durationis measured from the printout of the cardiac signal using standardpractice for determining the start and end of the QRS complex. Forexample, the QRS duration is measured between a point at which theinitial deflection for the Q-wave is sensed and a point where the S-wavereturns to baseline of the cardiac signal.

Alternatively, the duration of the QRS complex is measured automaticallyby an external surface ECG machine. For example, QRS complex durationintervals are measured from cardiac signals sensed from leads II and V₁of a PRM surface ECG system, where lead V₁ is placed at the fourthintercostal space, just to the right of the sternum.

At 330, the duration interval of the QRS complex is received by themedical device programmer as the first data value for use with the oneor more algorithms, where the one or more algorithms provide suggestionsfor therapy settings for an implantable pulse generator. In one example,the implantable pulse generator includes pacemaker functions, where thepacemaker functions could be operating in any number of implantable orexternal rhythm management devices (e.g., ICDs and/or pacemakers,implantable or external). Therapy settings suggested for the pacemakerfunction include, but are not limited to, which of either or bothventricular chambers to pace, a time interval for an AV-delay (thelength of time between an atrial sensed or atrial paced event and thedelivery of a ventricular output pulse, unless shortened by a sensedintrinsic ventricular event prior to the AV interval timing out) and/ora time interval for an LV offset (the length of time between a sensed orpaced event in a first ventricle and the delivery of an output pulse toa second ventricle).

Examples where suggested therapy settings would be useful include pulsegenerators that deliver pacing pulses to multiple ventricular or atrialsites, including so-called biventricular pacemakers where pacing pulsesare delivered to both ventricles by separate electrodes during a cardiaccycle. (See, e.g., U.S. Pat. Nos. 5,792,203 and 4,928,688, referred toherein as the '203 and '688 patents, which are hereby incorporated byreference.) Biventricular pulse generators have been found to be usefulin treating heart failure (HF), a clinical syndrome in which anabnormality of cardiac function causes cardiac output to fall below alevel adequate to meet the metabolic demand of peripheral tissues. HFcan be due to a variety of etiologies, with ischemic heart disease beingthe most common. Some HF patients suffer from some degree of AV blocksuch that their cardiac output can be improved by synchronizing atrialand ventricular contractions with dual-chamber pacing using a shortprogrammed AV delay time. It has also been shown, however, that some HFpatients suffer from intraventricular conduction defects (a.k.a. bundlebranch blocks). The cardiac outputs of these can be increased byimproving the synchronization of right and left ventricular contractionswith biventricular pacing. The present subject matter provides suggestedprogrammable parameter values for treating these cardiac conditions.

Ventricular Chamber

In one embodiment, the suggestion for which ventricular chamber to pace(left, right or both) is based on the sensed cardiac conduction betweenthe right and left ventricles of the heart. Different timingrelationships between cardiac complexes in the cardiac signals sensedfrom the right and left ventricular regions can indicate differentconduction disorder types. For example, in bundle branch block typedisorders regions of the left or right ventricle do not contracttogether in a coordinated fashion. As a result, the left and rightventricles do not contract simultaneously, but rather, the leftventricle contracts after the right ventricle or vice versa. As aresult, the pumping efficiency of the heart is reduced. To increase thepumping efficiency of the heart, identifying and selecting a ventricularpacing location, or locations, that allow for synchronized ventricularcontractions would be beneficial to patients with conduction disorderproblems.

Referring to FIG. 4, there is shown one embodiment of a method 400 forselecting a ventricular stimulation chamber for resynchronizationtherapy. At 410, a first cardiac signal is sensed from a rightventricular region and a second cardiac signal is sensed from a leftventricular region. In one embodiment, the first cardiac signal issensed from an apex of the right ventricular, while the second cardiacsignal is sensed from a left ventricular free wall. Alternatively, thefirst cardiac signal is sensed from any number of positions within theright ventricle and/or the second cardiac signal is sensed from anendocardial or transvenous location (i.e., lead implanted in coronaryvein with electrode adjacent LV). Other locations for sensing thesesignals are also possible. At 420, cardiac depolarizations are detectedin each of the first and second cardiac signals. In one embodiment, thecardiac depolarizations include R-waves, which are indications ofventricular contractions. The time at which the ventricular contractionsoccurred is then recorded, where R_(L) is designated as the time atwhich the depolarization in the left ventricle occurred and R_(R) isdesignated as the time at which the depolarization in the rightventricle occurred. In one embodiment, the time the R-wave occurred istaken as the peak (i.e., the point of maximum deflection duringdepolarization) of the R-wave.

At 430, the duration interval of the QRS complexes in the sensed cardiacsignals are measured. As previously discussed, measuring the durationinterval of QRS complexes is accomplished in any number of ways. Forexample, the duration interval of the QRS complex is measured manuallyfrom a paper strip chart of the patient's sensed cardiac signals orautomatically by an external surface ECG machine. At 440, thestimulation chamber, or chambers, are then determined based upon theduration interval of the QRS complexes and the time of occurrence forR_(L) and R_(R).

In one embodiment, the determination as to the ventricular chamber orchambers to pace is based on the comparison of the duration interval ofthe QRS complexes to an established value and the value of thedifference between R_(L) and R_(R). For example, when the durationinterval of the QRS complexes is greater than or equal to 120milliseconds and the difference between R_(L) and R_(R) (i.e.,R_(L)-R_(R)) is greater than 0 (zero), then the patient is likely a leftbundle branch block type. In this situation the recommended pacingchamber would be either the left ventricle or biventricular (leftventricle and right ventricle). Alternatively, when the durationinterval of the QRS complexes is greater than or equal to 120milliseconds and the difference between R_(L) and R_(R) (i.e.,R_(L)-R_(R)) is less than or equal to 0 (zero), then the patient islikely a right bundle branch block type. In this situation therecommended pacing chamber would be the right ventricle.

AV Delay Interval

The system and method of the present subject matter also allows for anAV delay interval to be computed from information derived from sensedcardiac signals. One example of computing an AV delay is described inU.S. patent application “System Providing Ventricular Pacing andBiventricular Coordination” commonly assigned Ser. No. 09/316,588, whichis hereby incorporated by reference. The suggested AV delay is thendisplayed as a suggested programmable value for the implantable pulsegenerator, which in this instance would be a dual chamber implantablepulse generator. In one embodiment, the AV delay is computed based atleast in part on an underlying intrinsic P-R interval. When programmedinto the implantable pulse generator the AV delay is used to time thedelivery of coordinated atrial/ventricular pacing therapy when atrialheart rhythms are not arrhythmic.

In one embodiment, the system obtains P-R intervals between atrialevents and successive ventricular events. In one embodiment, theintervals are calculated based on the sensed P-waves and R-waves. Thesystem computes an AV delay interval based at least on a most recent P-Rinterval duration and a previous value of the P-R interval. The systemcan then be used to program the implantable pulse generator to delivercoordinated atrial pacing and ventricular pacing pulses with the AVdelay interval.

Referring to FIG. 5, there is shown one embodiment of a method 500 forcomputing the AV delay interval. At 510, cardiac signals are sensed fromthe heart. In one embodiment, an atrial cardiac signal is sensed from anatrial location and a ventricular cardiac signal is sensed from aventricular location. Paced or sensed atrial events are detected in theatrial signal, and paced or sensed ventricular events are detected inthe ventricular signal. At 520, a duration of a P-R interval is measuredfrom a sensed atrial event and a subsequently sensed ventricular event.

The measured P-R interval is then provided as the first data value foruse with the one or more algorithms at 530. The one or more algorithmsthen use the measured P-R interval to determine and suggest an indicatedpacing interval, T_(n), for the AV delay at 440. In one example, theindicated pacing interval, T_(n), for the AV delay is described byT_(n)=a≅w≅AV_(n)+(1−w)≅T_(n-1), when AV_(n) is concluded by an intrinsicventricular beat, otherwise is described byT_(n)=b≅w≅AV_(n)+(1−w)≅T_(n-1), when AV_(n) is concluded by a pacedventricular beat, where T_(n-1) is the previous value of the indicatedP-R interval, AV_(n) is the time interval corresponding to the mostrecent P-R interval, and a, b, and w are coefficients. In oneembodiment, weighting coefficient w, intrinsic coefficient a, and pacedcoefficient b, are variables. Different selections of w, a, and b, willresult in different operation of the present method and apparatus. Forexample, as w increases the weighting effect of the most recent P-Rinterval (AV_(n)) increases and the weighting effect of the previousfirst indicated pacing interval T_(n-1) decreases. In one embodiment, wis equal to 1/16 (0.0625). In another embodiment, w is equal to 1/32.Another possible range for w is from w equal to ½ to w equal to 1/1024.A further possible range for w is from w approximately equal to 0 to wapproximately equal to 1. Other values of w, which need not includedivision by powers of two, may be substituted without departing from thepresent method and apparatus.

In one embodiment, intrinsic coefficient a, is selected to be less than(or, alternatively, less than or equal to) 1.0. In one example, theintrinsic coefficient a is selected to be lesser in value than thepacing coefficient b. In one embodiment, a is approximately 0.6 and b isapproximately 1.5. In another embodiment, a=1.0 and b=1.05. One possiblerange for a is from a=0.6 to a=1.0, and for b is from b=1.05 to b=1.5.The coefficients may vary without departing from the present method andapparatus.

In one embodiment, these coefficients are entered into the programmer bythe user. In another embodiment, the user selects a desired performanceparameter (e.g., desired degree pacing vs. sensing, desired attackslope, desired decay slope, etc.) from a corresponding range of possiblevalues, and the programmer automatically selects the appropriatecombination of coefficients to provide a filter setting that correspondsto the selected user-programmed performance parameter, as illustratedgenerally by Table 1. Other levels of programmability or differentcombinations of coefficients may also be used.

TABLE 1 Example of Automatic Selection of Aspects of Filter SettingBased on a User-Programmable Performance Parameter, Such as for AV DelayRegulation User-Programmable Intrinsic Paced Performance ParameterCoefficient a Coefficient b 1 (Less Aggressive 1.0 1.05 Attack/Decay) 20.9 1.2 3 0.8 1.3 4 0.7 1.4 5 (More Aggressive 0.6 1.5 Attack/Decay)

In a further embodiment, the implantable device uses a mapping, such asillustrated in Table 1, in a feedback control loop to automaticallyselect the “performance parameter” and corresponding coefficients. Theuser programs a mean sense frequency goal. The implantable pulsegenerator measures the mean frequency of sensed ventricular events(“measured mean sense frequency”) over a predetermined interval of timeor predetermined number of A-V intervals, and adjusts the performanceparameter and corresponding coefficients to direct the measured meansense frequency toward the mean sense frequency goal.

LV Offset

In addition to providing suggested AV-delay values, the present subjectmatter also provides a suggested LV offset value to be used in a cardiacrhythm management system having biventricular pacing. The suggested LVoffset value provides a time interval for pacing pulses to coordinatethe left and right ventricles for more efficient pumping. The system andmethod of the present subject matter compute an LV offset interval frominformation derived from sensed ventricular cardiac signals. Once thesuggested LV offset interval is determined, the value is displayed andcan subsequently be programmed into the implantable pulse generatorhaving the biventricular pacing capability. In one embodiment, the LVoffset interval is computed based at least in part on an underlyingintrinsic V-V interval and a previously stored value of a firstindicated pacing interval.

Referring to FIG. 6, there is shown one embodiment of a method 600 forcomputing the LV offset interval. At 610, cardiac signals are sensedfrom the heart. In one embodiment, a right ventricular cardiac signal issensed from a right ventricular location and a left ventricular cardiacsignal is sensed from a left ventricular location. From the right andleft ventricular cardiac signals, the duration interval of V-V intervalsbetween successive sensed or evoked ventricular contractions aremeasured at 620. These V-V intervals are referred to as the most recentV-V interval (VV_(n)).

The measured V-V interval is then provided as the first data value foruse with the one or more algorithms at 630. Based in part on theduration of the most recent V-V interval and a first indicated pacinginterval T_(n-1) the LV offset interval is calculated and suggested at640. In one embodiment, computing the LV offset is accomplished by usingthe value of the most recent V-V interval, VV_(n), and the previousvalue of the first indicated pacing interval T_(n-1). These values areeach scaled by respective constants a, w and b, and then summed toobtain a new value of the first indicated pacing interval (T_(n)). Inone embodiment, the coefficients a, w and b are different values, andare either programmable, variable, or constant.

If no ventricular beat is sensed during the new first indicated pacinginterval, T_(n), which is measured as the time from the occurrence ofthe ventricular beat concluding the most recent V-V interval VV_(n), aventricular pacing pulse is delivered upon the expiration of the newfirst indicated pacing interval T_(n). In one embodiment, the new firstindicated pacing interval T_(n) is described byT_(n)=a≅w≅VV_(n)+(1−w)≅T_(n-1), if VV_(n) is concluded by an intrinsicbeat, where a is an intrinsic coefficient, otherwise T_(n) is describedby T_(n)=b≅w≅VV_(n)+(1−w)≅T_(n-1), if VV_(n) is concluded by a pacedbeat, where b is a paced coefficient. In both equations, w is aweighting coefficient, VV_(n) is the most recent V-V interval duration,and T_(n-1) is the previous value of the first indicated pacinginterval. If no ventricular beat is sensed during the new firstindicated pacing interval T_(n), which is measured as the time from theoccurrence of the ventricular beat concluding the most recent V-Vinterval VV_(n), then a ventricular pacing pulse is delivered upon theexpiration of the new first indicated pacing interval T_(n).

The above-described parameters (e.g., a, b, w) are stated in terms oftime intervals (e.g., VV_(n), T_(n), T_(n-1)). However, an alternatesystem may produce results in terms of rate, rather than time intervals,without departing from the present method and apparatus. In oneembodiment, weighting coefficient w, intrinsic coefficient a, and pacedcoefficient b, are variables. Different selections of w, a, and b, willresult in different operation of the present method and apparatus. Forexample, as w increases the weighting effect of the most recent V-Vinterval VV_(n) increases and the weighting effect of the previous firstindicated pacing rate T_(n-1) decreases. In one embodiment, w is equalto 1/16 (0.0625). In another embodiment, w is equal to 1/32. Anotherpossible range for w is from w equal to ½ to w equal to 1/1024. Afurther possible range for w is from w approximately equal to 0 to wbeing approximately equal to 1. Other values of w, which need notinclude division by powers of two, may be substituted without departingfrom the present method and apparatus.

In one embodiment, intrinsic coefficient a, is selected to be greaterthan 0.5, or to be greater than 1.0. In one example, the intrinsiccoefficient a is selected to be lesser in value than the pacingcoefficient b. In one example, a is approximately equal to 1.1 and b isapproximately equal to 1.2. In another embodiment a=0.9 and b=1.1. Onepossible range for a is from a=0.5 to a=2.0, and for b is from b=1.0 tob=3.0. The coefficients may vary without departing from the presentmethod and apparatus.

In one example of determining an LV offset value, ventriculardepolarizations are detected in the sensed ventricular cardiac signals.V-V intervals are recorded between successive ventriculardepolarizations. In a first embodiment, the V-V interval is initiated bya right ventricular beat (paced or sensed), and the V-V interval is thenconcluded by the next right ventricular beat (paced or sensed). In asecond embodiment, the V-V interval is initiated by a left ventricularbeat (paced or sensed), and the V-V interval is then concluded by thenext left ventricular beat (paced or sensed). In a third embodiment, theV-V interval is initiated by either a right or left ventricular beat,and the V-V interval is then concluded by the next right or leftventricular beat that occurs after expiration of a refractory period ofapproximately between 130 milliseconds and 500 milliseconds (e.g., 150milliseconds). Left or right ventricular beats occurring during therefractory period are ignored. Using the refractory period ensures thatthe beat concluding the V-V interval is associated with a subsequentventricular contraction, rather than a depolarization associated withthe same ventricular contraction, in which the depolarization is merelysensed in the opposite ventricle from the initiating beat. Such arefractory period can also be used in conjunction with the firstembodiment (V-V interval initiated and concluded by right ventricularbeats) or the second embodiment (V-V interval initiated and concluded byleft ventricular beats).

Based on the measured V-V interval the first indicated pacing interval(T_(a)) (i.e., an LV offset) is computed. The first indicated pacinginterval is then displayed as a suggested value to be programmed forbiventricular pacing. Once programmed into the implantable pulsegenerator, the first indicated pacing interval is used to coordinate thecontractions of the right and left ventricles so as to provide moreefficient pumping of blood by the heart.

In one embodiment, the coefficients a, b, w are programmable by the userin order to obtain a desired degree of pacing vs. sensing. In anotherembodiment, the user selects a desired performance parameter (e.g.,desired degree of pacing vs. sensing, etc.) from a corresponding rangeof possible values, and programmer automatically selects the appropriatecombination of coefficients to provide a filter setting that correspondsto the selected user-programmed performance parameter, as illustratedgenerally by Table 2. Other levels of programmability or differentcombinations of coefficients may also be used.

TABLE 2 Example of Automatic Selection of Aspects of Filter SettingBased on a User-Programmable Performance Parameter Such as For ProvidingBiventricular Coordination Therapy. User-Programmable Intrinsic PacedPerformance Parameter Coefficient a Coefficient b 1 (More Pacing) 0.61.05 2 0.7 1.2 3 0.8 1.3 4 0.9 1.4 5 (Less Pacing) 1.0 1.5

In a further embodiment, a mapping is used, such as illustrated in Table2, in a feedback control loop to automatically select the “performanceparameter” of Table 2 and corresponding coefficients. The user programsa mean pacing frequency goal. The mean pacing frequency is measured overa predetermined interval of time or predetermined number of V-Vintervals. The measured mean pacing is compared to the mean pacingfrequency goal. If the measured mean pacing frequency is higher than thegoal mean pacing frequency, the performance parameter in Table 2 isincremented/decremented toward less pacing. Conversely, if the measuredmean pacing frequency is lower than the goal mean pacing frequency, theperformance parameter in Table 2 is incremented/decremented toward morepacing. In a further embodiment, the measured mean pacing frequency iscompared to values that are slightly offset about the goal mean pacingfrequency (e.g., goal mean pacing frequency +/−Δ) to provide a band ofacceptable measured mean pacing frequencies within which the performanceparameter is not switched.

Programmer

FIG. 7 shows one embodiment of a medical device programmer 700 accordingto the present subject matter. The medical device programmer 700 isadapted to be positioned outside the human body for communication withan implantable medical device 704. In one embodiment, a communicationlink 708 is established between the medical device programmer 700 andthe implantable medical device 704. In one embodiment, the communicationlink 708 is a radio frequency link.

In one embodiment, the medical device programmer 700 includes electroniccircuitry within a housing 710, where a graphics display screen 712 isdisposed on an upper surface 714 of the housing 710. The programmer 700further includes a drive 718 for reading and writing instructions usedby the electronic circuitry of the programmer 700. The graphics displayscreen 712 is operatively coupled to the electronic circuitry within thehousing 710 and is adapted to provide a visual display of graphicsand/or data to the user.

The programmer 700 further includes input devices to the electroniccircuitry. For example, the programmer 700 includes a touch-sensitivedisplay screen, such that the user interacts with the electroniccircuitry by touching identified regions of the screen with either theirfinger or with a stylus (not shown). In addition, the programmer 700further includes an alphanumeric key board 720 for providinginformation, such as programmable values for the implantable medicaldevice 704, to the electronic circuitry and the medical device 704.

The programmer 700 further includes a programming head 724. Theprogramming head 724 is used to establish the communication link 708between the electronic circuitry within the programmer 700 and theimplantable medical device 704. The telemetry link between theimplantable medical device 704 and the programmer 700 allows theelectronic circuitry coupled to the graphics display screen 712 to becoupled to the electronic control circuitry of the implantable medicaldevice 704. The programming head 724 is coupled to the electroniccircuitry of the medical device programmer through cable 728. FIG. 7also shows the programmer 700 having a printer 730 which allows forcardiac signals received from the implantable medical device 704 anddisplayed on the graphics display screen 712 to be displayed on a paperprintout 734. Adjustments for printer speed and scale of the printedcardiac signals is adjustable through the use of the display screen 712and the electronic circuitry within the programmer 700.

FIG. 8 shows one embodiment of control circuitry 800 for the programmer700. The control circuitry 800 includes a receiver/transmitter circuit808, a ventricular chamber selector 812, a controller 816, a memory 820,a data input/output 824, an in/out drive 830, a P-R delay determiner 836and an LV-offset determiner 840. These components are inner connectedand communicate via bus 844.

In one embodiment, the control circuitry receives a first data input, aspreviously described, through the data input 824. The control circuitry800 then executes one or more algorithms, as previously described, thatuse the first data value and calculates one or more suggested pulsegenerator settings from the one or more algorithms based on the firstdata value. The suggested pulse generator settings are then displayed onthe display screen (not shown in FIG. 8) for review by the user.

As previously discussed, the first data input can be used to suggest oneor more ventricular chambers in which to provide pacing pulses. For thisembodiment, the first data value is the duration interval of a QRScomplex. In one embodiment, the receiver/transmitter 808 receivesintrinsic intracardia electrograms recorded from the left and rightventricle, as previously discussed. The ventricular chamber selector 812then determines the difference between R_(L) and R_(R), where R_(L) isthe time at which the depolarization in the left ventricle occurred andR_(R) is the time at which the depolarization in the right ventricleoccurred. The ventricular chamber selector 812 then suggests one or moreventricular chambers in which to provide pacing pulses based on theduration interval of the QRS complex and the difference between R_(L)and R_(R), as previously described.

The first data input can also be used by the control circuitry 800 tosuggest a pacing interval, T_(n), for an AV delay based on the P-Rinterval. For this embodiment, the receiver/transmitter 808 receives anatrial cardiac signal having atrial events and a ventricular cardiacsignal having ventricular events, as previously described. The P-R delaydeterminer 836 then measures the duration interval of the P-R intervalbetween an atrial event and a ventricular event, and provides the P-Rinterval as the first data value for use with the one or morealgorithms. The P-R delay determiner 836 then suggests an indicatedpacing interval, T_(n), for an AV delay based on the P-R interval, aspreviously described.

The first data input can also be used by the control circuitry 800 tosuggest a pacing interval, T_(n), for an LV offset based on the V-Vinterval. For this embodiment, the receiver/transmitter 808 receives aright ventricular cardiac signal having ventricular events and a leftventricular cardiac signal having ventricular events, as previouslydescribed. The LV-offset determiner 840 then measures the durationinterval of the V-V interval between a right ventricular event and aleft ventricular event, and provides the V-V-interval as the first datavalue for use with the one or more algorithms. The LV-offset determiner840 then suggests an LV offset value based on the V-V-interval, aspreviously described.

FIGS. 9A, 9B, and 9C show examples of graphics display screen images fora medical device programmer, where each of the screen image represent aspecific stages in the three stage process previously described. In FIG.9A, there is shown a window 900 having three portions 904, 908 and 912.In the present example, screen portion 904 allows for patient profileinformation to be entered into the medical device programmer at inputwindow 914. Patient profile information entered in 914 is the mostrecently measured intrinsic QRS width (in milliseconds), determined aspreviously described.

Once a value of the most recently measured intrinsic QRS width has beenentered, the graphics display screen image changes to that seen in FIG.9B. In the example in FIG. 9B, the first portion 904 has darkened ascompared to FIG. 9A and displays the value of the most recently measuredintrinsic QRS width in the input window 914. In FIG. 9B, screen portion908 allows for the user to select at 920 between having the systemsuggest one or more ventricular pacing chamber and AV delay, or justproviding these suggestions automatically if the permanently programmedor suggested ventricular pacing chamber is biventricular. Informationrelating to the number and position of the electrodes is providedthrough information downloaded from the implantable pulse generator(e.g., default settings downloaded from the device or a serial number ofthe implanted device used to identify location and number of electrodes)or from input through the programmer by the physician at a screen priorto 908. Once the desired information is requested, the programmerestimates the time to completion and displays this information on thedisplay screen, as seen at 924. Once the desired test type has beenselected, the user starts the test by means of a start button 930.

Other settings that could potentially be offered based on the QRSduration information include, but are not limited to, sensed AV delayoffset, intrachamber ventricular pacing sites and/or atrial pacingsites. These sites are specific positions to locate the lead inside achamber to achieve optimal therapy, as opposed to just provide achamber. This position could be anterior, lateral, mid-lateral,posterior, or other any of a number of other positions within the heart.

When the test is complete, the graphics display screen image changes tothat seen in FIG. 9C. In FIG. 9C, the third portion 912 of the window900 is illuminated and contains the suggested settings for AV delay,ventricular pacing chamber and LV Offset (if applicable) at 936.Included in the suggested settings are dynamic AV delay which is alwayssuggested as off to allow the suggested fixed AV delay to be used, andsensed AV delay offset which is always suggested to the same value asits permanent setting. To account for the sensed AV delay offset, thesuggested AV delay is adjusted by the sensed AV delay offset amount sothat when the sensed AV delay offset amount is subsequently subtractedfrom the suggested AV delay the resulting AV delay will be theoriginally suggested value of the AV delay.

In one embodiment, the suggested settings are either modified or kept assuggested by the programmer. When the user is finished, the suggestedsettings can then be copied into the change column for the permanentBrady/HF therapy settings and successively programmed into theelectronic control circuitry of the implantable pulse generator as thepermanent settings.

Implantable Pulse Generators

FIG. 10 is a schematic drawing illustrating generally by way of example,but not by way of limitation, one embodiment of an implantable pulsegenerator 1000 coupled by leads 1004, 1008 and 1012 to a heart 1020. Inone such embodiment, the implantable pulse generator 1000 providesbiventricular coordination therapy to coordinate right ventricular andleft ventricular contractions, such as for heart failure patients. FIG.10 includes a left ventricular lead 1004, inserted through coronarysinus 1024 and into the great cardiac vein so that its electrodes, whichinclude electrodes 1030 and 1032, are associated with left ventricle1036 for sensing intrinsic heart signals from the left ventricle 1036and providing one or more of coordination paces or defibrillationshocks. A right ventricular lead 1008 is also shown in FIG. 10, wherethe lead 1008 is inserted through the superior vena cava 1040 and theright atrium 1048 into the right ventricle 1052 so that its electrodes,which include electrodes 1058, 1060 and 1064, are associated with theright ventricle 1052 for sensing intrinsic heart signals from the rightventricle 1052 and providing one or more of coordination paces ordefibrillation shocks. FIG. 10 also includes a right atrium lead 1012,where the right atrium lead 1012 is inserted through the superior venacava 1040 into the right atrium 1048 so that its electrodes, whichinclude electrodes 1080 and 1084, are associated with the right atrium1048 for sensing intrinsic heart signals from the right atrium 1048 andproviding one or more coordination paces shocks.

The implantable pulse generator 1000 further includes a connector block1088 adapted to releasable couple leads 1004, 1008 and 1012 to the pulsegenerator and to couple the electrodes located on the leads to theelectronic control circuitry located within the implantable pulsegenerator 1000. The electronic circuitry within the implantable pulsegenerator 1000 senses cardiac signals from the heart and provideselectrical pulses, such as pacing and/or defibrillation pulses, underpredetermined conditions of the heart 1020. The electronic circuitryalso contains transmitting and receiving circuitry for communicatingwith an external medical device programmer, as previously described.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat any arrangement which is calculated to achieve the same purpose maybe substituted for the specific embodiment shown. This application isintended to cover any adaptations or variations of the presentinvention. Therefore, it is intended that this invention be limited onlyby the claims and the equivalents thereof.

1. An external medical device to communicate with an implantable device,the external device comprising: a user interface configured to receive aprompt to generate one or more therapy settings for the implantabledevice; a pacing site selector configured to: receive a measure of a QRScomplex duration into pacing site selector input; measure a time ofoccurrence of a peak of depolarization of a right ventricle (RV) and atime of peak of occurrence of depolarization of a left ventricle (LV);determine, as a first generated therapy setting, a pacing site accordingto the measure of QRS complex duration and the time relationship of thedepolarization peak of the RV and the depolarization peak of the LV; andprovide the determined pacing site to at least one of a user or process.2. The external medical device of claim 1, wherein the pacing siteselector is configured to: select a pacing site in the RV when themeasured QRS complex duration exceeds a specified duration threshold andthe difference between the time of occurrence of the depolarization peakof the LV and the time of occurrence of the depolarization peak of theRV is less than or equal to zero; and select a pacing site in the LVwhen the measured QRS complex duration exceeds a specified durationthreshold and the difference between the time of occurrence of thedepolarization peak of the LV and the time of occurrence of thedepolarization peak of the RV is less than or equal to zero.
 3. Theexternal medical device of claim 1, wherein the external device includesa receiver/transmitter communicatively coupled to the pacing siteselector input, and wherein the pacing site selector is configured to:initiate a communication of a request to the implantable device inresponse to the user prompt; receive a representation of a sensed RVcardiac signal sensed and a representation of a sensed LV cardiac signalin response to the communicated request; measure the QRS complexduration using at least one of cardiac signals; measure the time ofoccurrence of a peak of depolarization of the RV using the RV cardiacsignal; and measure the time of occurrence of a peak of depolarizationof the LV using the LV cardiac signal.
 4. The external medical device ofclaim 1, including an LV offset determiner configured to: measure, inresponse to the prompt received via the user interface, a durationinterval between a cardiac event in the RV and a cardiac event in theLV; and calculate, as a second generated therapy setting, an LV offsetinterval using the measured duration interval.
 5. The external medicaldevice of claim 4, including: a receiver/transmitter communicativelycoupled to the LV Offset determiner, and wherein the LV Offsetdeterminer is configured to: initiate communication of a request to theimplantable device in response to the user prompt; receive arepresentation of a sensed RV cardiac signal sensed and a representationof a sensed LV cardiac signal in response to the communicated request;and measure the duration interval using the received representations ofthe sensed cardiac signals.
 6. The external medical device of claim 4,wherein LV Offset determiner is configured to: calculate the LV offsetinterval using a first set of calculation coefficients when the measuredtime duration ends with an intrinsic cardiac event; and calculate the LVoffset interval using a second set of calculation coefficients when themeasured time duration ends with a paced cardiac event.
 7. The externalmedical device of claim 4, wherein LV Offset determiner is configuredto: determine a frequency with which pacing therapy is delivered by theimplantable device; compare the determined frequency of pacing to aspecified pacing frequency value; and adjust calculation coefficientsused to calculate the LV offset interval according to the comparison. 8.The external medical device of claim 1, including a PR delay determinerconfigured to: measure, in response to the prompt received via the userinterface, a time interval between a cardiac event in an atrium and acardiac event in the ventricle; and calculate, as a second generatedtherapy setting, an AV delay interval using the measured time interval.9. The external medical device of claim 8, wherein the PR delaydeterminer is configured to: initiate a communication of a request tothe implantable device in response to the user prompt; receive arepresentation of a cardiac signal sensed in an atrium and arepresentation of a cardiac signal sensed in a ventricle in response tothe communicated request; and measure the time interval using thereceived representations of the sensed cardiac signals.
 10. The externalmedical device of claim 8, wherein the PR delay determiner is configuredto: calculate the AV delay interval using a first set of calculationcoefficients when the measured time interval ends with an intrinsicventricular event; and calculate the AV delay interval using a secondset of calculation coefficients when the measured time interval endswith a paced ventricular event.
 11. The external medical device of claim8, wherein the PR delay determiner is configured to: determine afrequency with which intrinsic ventricular events are sensed by theimplantable device; compare the frequency of intrinsic ventricularevents to a specified sensed event frequency value; and adjustcalculation coefficients used to calculate the AV delay intervalaccording to the comparison.
 12. A method of operating an externaldevice, wherein the external device is capable of communicating with animplantable device, the method comprising: receiving a prompt via a userinterface of the external device to generate one or more therapysettings for the implantable device; receiving a measure of a QRScomplex duration into the external device; measuring, with the externaldevice, a time of occurrence of a peak of depolarization of a rightventricle (RV) and a time of peak of occurrence of depolarization of aleft ventricle (LV); and determining with the external device, as afirst generated therapy setting, a pacing site according to the measureof QRS complex duration and the time relationship of the depolarizationpeak of the RV and the depolarization peak of the LV, and wherein theexternal device provides the determined pacing site to at least one of auser or process.
 13. The method of claim 12, wherein determining apacing site includes: selecting a pacing site in the RV when themeasured QRS complex duration exceeds a specified duration threshold andthe difference between the time of occurrence of the depolarization peakof the LV and the time of occurrence of the depolarization peak of theRV is less than or equal to zero; and selecting a pacing site in the LVwhen the measured QRS complex duration exceeds a specified durationthreshold and the difference between the time of occurrence of thedepolarization peak of the LV and the time of occurrence of thedepolarization peak of the RV is less than or equal to zero.
 14. Themethod of claim 13, wherein receiving a measure of a QRS complexduration into the external device includes: communicating a request tothe implantable device in response to the user prompt; receiving arepresentation of a sensed RV cardiac signal and a representation of asensed LV cardiac signal in response to the communicated request; andmeasuring the QRS complex duration using at least one of the cardiacsignals, and wherein measuring the time of occurrence includes measuringa time of occurrence of a peak of depolarization of the RV using therepresentation of the RV cardiac signal measuring a time of occurrenceof a peak of depolarization of the LV using the representation of the LVcardiac signal.
 15. The method of claim 12, wherein measuring the timeinterval includes: communicating a request to the implantable device inresponse to the user prompt; receiving a representation of a cardiacsignal sensed in the RV and a representation of a cardiac signal sensedin the LV in response to the communicated request; measuring, with theexternal device, a duration interval between a cardiac event in the RVand a cardiac event in the LV using the received representations of thesensed cardiac signals; and calculating, as a second generated therapysetting, an LV offset interval using the measured duration interval. 16.The method of claim 15, wherein calculating an LV offset intervalincludes: calculating the LV offset interval using a first set ofcalculation coefficients when the measured time duration ends with anintrinsic cardiac event; and calculating the LV offset interval using asecond set of calculation coefficients when the measured time durationends with a paced cardiac event.
 17. The method of claim 15, including:determining, with the external device, a frequency with which pacingtherapy is delivered by the implantable device; comparing, using theexternal device, the determined frequency of pacing to a specifiedpacing frequency value; and adjusting, by the external device,calculation coefficients used to calculate the LV offset intervalaccording to the comparison.
 18. The method of claim 12, including:communicating a request to the implantable device in response to theuser prompt; receiving, into the external device, a representation of acardiac signal sensed in an atrium and a representation of a cardiacsignal sensed in a ventricle in response to the communicated request;measuring, with the external device, a time interval between a cardiacevent in an atrium and a cardiac event in the ventricle using thereceived representations of the sensed cardiac signals; and calculating,using the external device, an AV delay interval as a second generatedtherapy setting using the measured time interval.
 19. The method ofclaim 18, wherein calculating the AV delay interval includes:calculating the AV delay interval using a first set of calculationcoefficients when the measured time interval ends with an intrinsicventricular event; and calculating the AV delay interval using a secondset of calculation coefficients when the measured time interval endswith a paced ventricular event.
 20. The method of claim 18, determining,with the external device, a frequency with which intrinsic ventricularevents are sensed by the implantable device; comparing, using theexternal device, the frequency of intrinsic ventricular events to aspecified sensed event frequency value; and adjusting, by the externaldevice, calculation coefficients used to calculate the AV delay intervalaccording to the comparison.